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文章出处:Technology|阅读量:419|发表时间:2021-02-25
Biosafety laboratories, just by hearing the name, you know that "safety" is the first element. The construction of biosafety laboratories takes biological research as the core, while ensuring the safety of laboratory staff, experimental environment and the surrounding environment of the laboratory. . According to the protective measures taken for the biological factors operated, the laboratory biosafety protection level is divided into level 1, level 2, level 3 and level 4. The level 1 protection level is the lowest and the level 4 protection level is the highest. Therefore, when building a biosafety laboratory, its design basis has three main goals: safety, information, and intelligence. CEIDI Xidi designer participated in the 2019 Future Laboratory Innovation and Development Summit Forum this year. Mr. Xie Jingxin, secretary of the Occupational Disease Control Institute of Jiangsu Center for Disease Control and Prevention and deputy director of the Laboratory Biosafety Professional Committee of the Chinese Society of Microbiology, designed the system for biological laboratories. And explained many design points in detail. CEIDI Xidi, a Shanghai laboratory and clean room engineering EPC integration service provider, will explain how to correctly build a biosafety laboratory for you. First of all, I want to talk about the construction standards of biosafety laboratories. You can go to relevant websites to search for these reference standards.
I. Reference specifications for biosafety laboratories
1. GB19489-2008 "Laboratory Biosafety General Requirements"
2. GB50346-2011 "Technical Code for Biosafety Laboratory Building"
3. CANS-CL53 (CNAS-CL05-A002) "Application Note of Laboratory Biosafety Accreditation Criteria for Evaluation of Key Protective Equipment"
4. "Guidelines for the Work of Clinical Gene Amplification Laboratory in Medical Institutions"
5. "PCR test laboratory gene amplification test laboratory work guidelines"
6. "Guidelines for PCR Testing Laboratory Inspection Points"-2016 Edition
7. GBT32146-2015 "Technical Requirements for the Design and Construction of Inspection and Testing Laboratories"
8. GB50447-2018 "Technical Planning for Laboratory Animal Facilities Construction"
9. GB50591-2010 "Code for Clean Room Construction and Acceptance"
10. GB50881-2013 "Technical Code for Construction of Centers for Disease Control and Prevention"
11. Building Standard 127-2009 "Standards for the Construction of Centers for Disease Control and Prevention"
12. Health Office CDC [2004] No. 108 "Guiding Opinions on the Construction of CDC Laboratories at All Levels"
13. "List of Microorganisms in Hospitals for Human Infectious Diseases" Health Science Education Development [2006] No. 15, 2006, 01.11
14. "Classified List of Animal Pathogenic Microorganisms" Ministry of Agriculture Order No. 53, 2005.05.24
II. Common problems in the decoration design of biological laboratories
1. The PCR corridor is not standard. Don't make PCR corridors hard when the depth is not enough, and PCR corridors will increase cross-contamination. The four common partitions of the PCR laboratory (reagent storage and preparation area, specimen preparation area, nucleic acid amplification area, and product analysis area) originally have no hard and fast rules to be connected together. In physical space, these four partitions must be completely Independent, and should be completely separated during use, without direct air communication.
2. The transfer window is not necessarily set. As long as it does not involve clean and dirty diversion, no transfer window is required. The essence of the transfer window is the same as the buffer room. The transfer window is the buffer room of logistics. When we design a biological laboratory, it is best not to add a transfer window in the reagent preparation room and the specimen preparation room to prevent cross contamination.
3. The so-called "polluted area" and "semi-polluted area" have been cancelled in GB19489-2008. In addition, the laboratory corridors are divided into clean corridors and dirt corridors, which are also backward concepts many years ago. Only the animal laboratory needs a dirt corridor. As a laboratory designer, you must always pay attention to the adjustment of relevant specifications and regulations to avoid low-level errors in laboratory design work. This is also the reason why SAREN laboratory has always insisted on cultivating internal talents and continuous learning.
III. The overall plan for the planning and design of the biosafety laboratory
The construction of a biosafety laboratory should be considered from multiple aspects and combined with various gradient requirements to design a feasible plan suitable for the experimental environment. With economy and environmental protection as the primary requirement, it is mainly aimed at the laboratory’s building layout and decoration, air conditioning, water supply and drainage , Gas supply, electrical design, centralized control, security, construction technology, testing, personnel training, etc. The following mainly explains the five major planning and construction programs.
①The basis for the safe operation of a biosafety laboratory: building layout and decoration plan. The layout of the laboratory is reasonably divided into clean area, semi-contaminated area and contaminated area according to safety requirements. Special passages are set up for people and objects, necessary buffer rooms are set up, and measures such as primary isolation and secondary isolation are adopted to effectively avoid intersection Pollution, fundamentally prevent the spread of dangerous microorganisms; reliable materials and reasonable construction measures are used for laboratory decoration to ensure that the aseptic laboratory is always in a relatively sealed environment to prevent the escape of microorganisms and facilitate the cleaning of the aseptic laboratory Sterilize, while avoiding damage to the sterile laboratory from the external environment.
②The key to safe operation of biosafety laboratory: air conditioning system. Since the operating objects in the microbiology laboratory are dangerous microorganisms, which are harmful to the human body, animals and plants or the environment, a reasonable air conditioning system must be adopted to keep the relative negative pressure environment of the microbiology laboratory from being destroyed at any time. Ensure that dangerous microorganisms in the laboratory cannot spread to the external environment. The air-conditioning system must operate reliably, adopt advanced technology, reasonably utilize and save energy and resources, ensure the quality and safety of the environment, provide the required temperature and humidity for the experimenters, and ensure that the biological experiment is carried out under safe conditions to ensure the experiment The results are accurate. At the same time, it must also control the cleanliness of the laboratory and filter the fresh air to achieve a certain degree of purification. The exhaust system plays an important role in ensuring a relatively negative pressure environment in the laboratory and effectively filtering indoor pollution and exhaust air.
③The nerve center of the safe operation of the biosafety laboratory: the control system. Since the experimental objects of the biosafety laboratory are dangerous microorganisms, based on the principle of strict pollution control, it requires a minimum of maintenance personnel and the use of optimized management and maintenance methods to monitor the equipment in each laboratory in real time. The physical environment ensures that the laboratory is always in a relatively negative pressure environment during the operation of the laboratory to prevent the leakage of dangerous microorganisms.
④Assurance of the long-term safe operation of the biosafety laboratory program: testing program. Due to the particularity of the microbiology laboratory, in addition to strict design, construction, and debugging, to ensure its performance, it must be subjected to necessary engineering testing and strict acceptance, and it can be put into operation after meeting the requirements and use requirements. In addition, some factors in the use process, such as non-professional management and use, replacement of high-efficiency filters, etc., will have an impact on the performance of the laboratory. Therefore, regular testing during use is equally important.
⑤In addition, for the daily work of the laboratory, the safety of laboratory personnel is always the first priority, so an important construction plan of the biosafety laboratory, namely the training program: due to the clean laboratory-biosafety laboratory Laboratory personnel are usually medical experts, and they may not have a good understanding of the principles of the entire laboratory system. Through training programs, all laboratory staff can understand the characteristics of the entire system and master its operation rules, so that potential safety hazards can be discovered in time and made in time. Corresponding emergency response to control the further deterioration of the situation is of great help in reducing the difficulty of subsequent maintenance work.
IV, the 16 main system structures of the decoration design of the biological laboratory
System 1: Laboratory structure. The biological laboratory uses polystyrene sandwich color steel plates as the ceiling and enclosure partition materials, because this type of material has high strength, waterproof and thermal insulation. The angle between the wall and the ground, the wall and the top plate should use aluminum alloy arc yin and yang transition and sealing. The ground should be seamlessly connected with plastic PVC flooring, which is wear-resistant and non-slip.
System 2: Cleanliness and pressure gradient. It is mainly divided into two parts: contaminated area and experimental operation room.
System 3: Airflow organization method. The direction of air flow is from the clean area to the polluted area. The specific process is buffer dressing area → shower room → secondary dressing → clean corridor → preparation room → semi-contaminated area → primary buffer → wear protective clothing → secondary buffer → operating room → biological safety cabinet .
System 4: Air conditioning system. The air conditioning system of the biological laboratory must satisfy the cooling effect in summer and heating effect in winter.
System 5: Laboratory air supply and exhaust system. The air supply and exhaust system of the biological laboratory controls the six areas of the experimental operation room, the secondary buffer, the semi-contaminated area, the primary buffer and preparation room, the clean dressing area, and the clean corridor.
System 6: Room pressure display and alarm system. After installing this system, the staff can know the pressure situation in the laboratory in time. When the pressure exceeds or does not reach the predetermined range, it will alarm and remind the staff to make adjustments.
System 7: Electronic interlocking system. In order to prevent the loss of pressure caused by the simultaneous opening of two doors in the laboratory, the buffer room of the biological laboratory needs to be installed with an electronic interlocking system, such as an electronic interlocking door. In this way, when one door is opened, the other interlocked door will not open at the same time.
System 8: Air volume automatic control system. In the main experimental area of the biological laboratory, or in multiple laboratories, imported mechanically operated constant air volume regulating valves and variable air volume regulating valves should be installed on the main air supply pipeline to keep the pressure in the laboratory constant. Biological laboratory decoration design: reference specifications, common problems, system structure, overall plan
System 9: Anti-airflow backflow system. As long as the biological laboratory has installed this system, it can prevent the air backflow caused by the shutdown of the air supply and exhaust system, and also has the effect of closed disinfection.
System 10: Laboratory items in and out. In fact, whether it is a biological laboratory or other types of laboratories, due to the special environment in the laboratory, the entry and exit of the staff and related experimental items must be sterilized and disinfected.
System 11: Laboratory gas pipeline connection. In the connection of gas pipelines, two things must be done well, one is the gas pipe joint for experiment, and the other is the installation of the valve, which can prevent the gas cylinder of the instrument from being directly put into the laboratory operation area.
System 12: Data transmission system. The data transmission system of the biological laboratory includes network cables, telephone and fax lines, etc., which facilitate the real-time transmission and sharing of data between the laboratory and the outside.
System 13: Monitoring system. There are many types of surveillance systems, here mainly refers to closed-circuit television surveillance video systems. This system consists of a host and multiple zoom cameras. The host is installed in the central control room and the cameras are installed in other rooms. After installation, the laboratory operation room, semi-contaminated area, preparation room and other areas can be controlled to facilitate the observation of the operation process of each experiment room.
System 14: Communication system. Also known as the intercom system, it mainly refers to various telephones in the laboratory to facilitate communication between staff.
System 15: Access control system. The access control system of the biological laboratory must have a high identification code lock, which is not only beneficial to the information management of the staff, but also can ensure the safety of the laboratory.
System 16: Power distribution system form and configuration. The power distribution system of the biological laboratory is in the form of TN-S220V/380V, which is configured as a general distribution box, a special interlocking start and stop distribution box for air supply and exhaust, and a control air supply and exhaust fan and a chain backup fan. One lighting control box, several lighting, sockets, and biological safety cabinets. In addition, the power supply should be equipped with a leakage detection alarm device, a reliable power connection system, and its grounding resistance should not be greater than 1Ω. The entrance of the laboratory should have a textual light signal display of the working status of the laboratory, and an emergency light-emitting evacuation indicator should be set.